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GlaxoSmithKline Receives New HHS Order for H5N1 Bulk Antigen. First North American Clinical Trials with GSK's Candidate Pre-pandemic Flu Vaccine to Start.
Date:8/19/2007

PHILADELPHIA, Aug. 3 /PRNewswire-FirstCall/ -- GlaxoSmithKline (NYSE: GSK), one of the world's largest vaccine manufacturers, today announced that HHS has placed another order to purchase bulk H5N1 antigen for the US national stockpile of pre-pandemic vaccines. The company also announced the start of the first North American pre-pandemic vaccine trials in the company's global pre-pandemic influenza program.

HHS Order

The company has received a second task order for 22.5 million doses of 15 mcg H5N1 bulk vaccine antigen from the U.S. Department of Health and Human Services (HHS) under a contract [HHS100200700027I] awarded in November 2007. This is in addition to the 5 million doses of H5N1 clade 2 bulk antigen at 15 mcg HA/dose ordered in November 2006. The additional task order procures an additional 9 million doses of H5N1 clade 2 bulk vaccine produced in the 2006 manufacturing campaign and 13.5 million doses of H5N1 clade 2 bulk vaccine expected to be produced in the 2007 manufacturing campaign.

Under the terms of the contract, GSK will manufacture the bulk vaccine product at the GSK manufacturing site in Ste. Foy, Canada and store bulk H5N1 antigen at the GSK site in Marietta, PA. Terms of the contract also state that GSK may be directed by HHS to formulate this bulk antigen at some point in the future. Additionally, HHS also has the option to purchase pre-pandemic vaccines together with one of GSK's proprietary adjuvant systems, which could mean that less antigen would be needed per dose to achieve a protective immune response. Funding for this contract is provided through the Office of Biomedical Advanced Research and Development Authority (BARDA) in the Assistant Secretary for Preparedness and Response (ASPR).

David Stout, President, Pharmaceutical Operations, GlaxoSmithKline said: "We applaud the US government's proactive steps in protecting American citizens against this potential public health threat. We are committed to helpi
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SOURCE GlaxoSmithKline

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